Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 2 - Premenopausal Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dense Breasts
- Sponsor
- Mayo Clinic
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- proportion of epithelium vs stroma
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The investigators hypothesize that knowledge of the functional behavior of areas of mammographic density will enable more specific identification of dense tissue at-risk for breast cancer, ultimately providing predictive information on an individual's risk of developing breast cancer.
Detailed Description
The specific aims are: * In women with increased mammographic density (MD), determine the histological characteristics of functionally dense tissue compared to that of non-functionally dense tissue via core-needle biopsy of the breast. * In women with increased mammographic density (MD), determine the correlations between the total percent area of functional density (FD) on MBI, percent density of MD on mammogram, and histological characteristics of dense tissue
Investigators
Carrie Hruska
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Ages 40 - 55 years
- •Considered premenopausal or peri-menopausal
- •Screening mammogram performed at Mayo Clinic Rochester within one year prior to the current MBI study which demonstrates
- •Negative/benign assessment (BIRADS category 1-2) or Additional imaging recommended (BIRADS category 0), where the subsequent diagnostic workup results in a final negative/benign assessment (BIRADS category 1-2).
- •No proliferative benign lesions (e.g. fibroadenomas) identified
- •Heterogeneously dense or extremely dense parenchyma (BIRADs density category 3 or 4)
- •MBI performed less than 3 days prior to biopsy demonstrating either marked FD or photopenic FD in an area of mammographically dense tissue amenable to biopsy.
- •No use of exogenous hormonal drugs (e.g. hormonal contraceptives or sex steroid hormones) within six months prior to study biopsy
- •Negative pregnancy test or surgically sterilized (for patients in whom a study MBI will be performed)
- •Exclusion criteria:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
proportion of epithelium vs stroma
Time Frame: within 3 days of functional density assessment on MBI
Secondary Outcomes
- Ki-67 cellular proliferation index(within 3 days of functional density assessment on MBI)
- Degree of lobular involution(within 3 days of functional density assessment on MBI)